Panel themes of the International Conference “Europe against Counterfeit Medicines”

1. Panel themes of the International Conference “Europe against Counterfeit Medicines” G.N. Gildeeva, Deputy head of the Department of Registration of Medicines and Medical Devices, Federal Inspectorate for Health and Social Development (Roszdravnadzor)

2. Aims • Help create effective legislative machinery to reduce the number of counterfeits on the pharmaceutical market, improve law enforcement practice and develop co-operation between the Russian Federation and member states of the Council of Europe, the EU and the WHO; • Draft an appropriate legal instrument (convention) on international co-operation in the fight against counterfeit medicines; • Secure a consensus between the public and private sectors as regards practical measures to protect society and the economy from the detrimental consequences of counterfeit medicines; • Ensure effective sharing of information and best practice, by establishing a network of Single Points of Contact in the relevant state agencies, most notably healthcare institutions; • Create a special network of quality control laboratories in the Russian Federation in consultation with the European Directorate for the Quality of Medicines (EDQM).

3. Russian participants • Officials from the Russian federal executive and legislative authorities • Officials from the regulatory oversight and security agencies • Representatives of the agencies involved in the fight against counterfeit medicines • Officials from the RF Government and the President’s Office • Representatives of the CIS countries • Representatives of international and European institutes and organisations, and private companies involved in the manufacture and sale of pharmaceuticals • Representatives of patient and consumer protection groups • Pharmaceutical industry organisations and associations

4. Some basic facts • The counterfeiting of medicines is a global problem. • Counterfeit medicines pose a threat to the nation’s health. • Any counterfeit medicine has the potential to damage the patient’s health. • Counterfeiting medicines has a direct negative impact on consumers and manufacturers alike. • The system of combating the spread of counterfeit medicines will only work if there is an appropriate legislative framework. • The counterfeiting of medicines can be prevented only if all members of society make a concerted effort.

5. Panel 1 Government, enforcement and training perspectives • Moderator: A.A. Toporkov, deputy head of the Department of State Regulation of Trade in Medical Products and Methods of Rehabilitating People with Disabilities, Roszdravnadzor • Key themes • National strategy for combating trade in counterfeit medicines • Law enforcement agencies: combating trade in counterfeit medicines • Training staff in the healthcare sector, customs authorities, Ministry of Internal Affairs, judiciary, etc., to combat trade in counterfeit medicines and fight crime in this area by legal means; • Inter-ministerial co-ordination

6. Panel 2 Legislative agenda Moderator: Boris Spiegel, deputy head of the Federation Council Committee on Science, Culture, Education, Healthcare and Ecology Rapporteur I.V. Filippov, State Duma Key themes: • Current Russian legislation to combat trade in counterfeit medicines • Administrative regulation of interaction between the competent ministries and law enforcement agencies • Objectives of international co-operation

7. Panel 3 International co-operation: laboratories and analytical controls Moderator: V.V. Kosenko, head of the Department of State Regulation of Trade in Medical Products and Methods of Rehabilitating People with Disabilities, Roszdravnadzor Rapporteur: R.I. Yagudina, director of the Institute of Information Technology, Federal State Agency “Research Centre for the Evaluation of Medicinal Products”, Roszdravnadzor Key themes: • The system of state control and monitoring of medicines • Practical experience of organising expert testing of medicines • Development of the regional medicine quality control service

8. Panel 4 Public-private perspectives and partnership in the public health sphere Moderator: D.V. Parkhomenko, deputy head of the Department of State Regulation of Trade in Medical Products and Methods of Rehabilitating People with Disabilities, Roszdravnadzor Rapporteur: L.V. Titova, Association of Russian Pharmaceutical Manufacturers, Russia Key themes: • Measures to make patients, consumers and staff aware of the potential risk and possible consequences of using counterfeit medicines • Role of pharmaceutical and medical workers’ organisations, the media, consumer and patient protection groups • Interaction between the state and manufacturers in combating trade in counterfeit medicines

9. Panel 5 Best practices to protect consumers and the market Moderator: V.A. Dmitriev, Roszdravnadzor, Russian Federation Rapporteur: F.Y. Vartanyan, Russian Medical Academy of Postgraduate Studies, MoscowKey themes: • A system for controlling the quality of medicines and detecting counterfeits • Technologies for combating the manufacture of and trade in counterfeit medicines

10. Panel 6 European Directorate for the Quality of Medicines (EDQM) Moderator: G.N. Gildeva, deputy head of the Department of Registration of Medicines and Medical Devices, Roszdravnadzor Rapporteur: V. L. Bagirova, Director of the Institute of Standardisation and Regulation of Medicines, Federal State Agency “Research Centre for the Evaluation of Medical Products”, Roszdravnadzor Key themes: • Issues relating to the standardisation of medicines – prospects for the harmonisation of the Russian Pharmacopoeia with the European Pharmacopoeia • Co-operation with the European Directorate of the Quality of Medicines

11. Conclusion • The programme to combat trade in counterfeit medicines will only work if the necessary legislation is put in place, and strictly enforced. This requires concerted efforts and co-operation on the part of both civil society and the private sector. • In order to implement practical measures to improve the safety of medicines, close contacts needed to be developed at all levels of government in the Russian Federation with the Council of Europe. • An international convention to combat trade in counterfeit medicines needs to be adopted within the framework of the Council of Europe.